EUCTR2017-000957-37-GR进行中（未招募）1 期
A Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis
CB Biopharma SPR0 个研究点目标入组 60 人开始时间: 2017年9月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Documented diagnosis of active adult-onset Ankylosing Spondylitis (AS) as defined by documented
- •radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984) of at least 3 months’ symptom duration and age of onset <45 years
- •- Subject has moderate to severe active disease at the Screening Visit as defined by each of the following:
- •a) BASDAI score >=4
- •b) Spinal pain >=4 on a 0 to 10 numeric rating scale (NRS) (from BASDAI Item 2)
- •- Subjects must have had an inadequate response to, have a contraindication to, or have been intolerant to
- •at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs)
- •- Subjects taking corticosteroids must be on a maximum daily dose of <=10mg/day oral prednisolone or
- •- Subjects taking methotrexate (MTX; <=25mg/week) are allowed to continue their medication if they
- •received a stable dose for at least 12 weeks before randomization
- •- Subjects taking sulfasalazine (up to 3grams/day) or hydroxychloroquine (up to 400mg per day total) are
- •allowed to continue their medication if started at least 12 weeks prior to randomization
- •- Subject who has been on an anti-TNF agent must have experienced an inadequate response to previous
- •or current treatment given at an approved dose for at least 3 months or have been intolerant to at least 1
- •administration of an anti-tumor necrosis factor alpha (TNF) agent. Subjects may not have been on more
- •than 1 anti-TNF agent.
- •- Subject has high-sensitive C-Reactive Protein (hsCRP) levels above ULN at the Screening Visit
- •- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must
- •be willing to use a highly effective method of contraception up till 20 weeks after last administration of
- •Investigational Medicinal Product (IMP)
- •- Male subjects with a partner of childbearing potential must be willing to use a condom when sexually
- •active, up till 20 weeks after the last administration of IMP
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Subjects with a total ankylosis of the spine, or a diagnosis of any other inflammatory arthritis
- •eg,rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus, or reactive arthritis
- •- Subjects with any current sign or symptom that may indicate an active infection (except for the
- •common cold)
- •- Subject has received previous or current biological treatment other than TNF inhibitor treatment
- •- Subject has chronic, recurrent, recent serious / life-threatening or current infection, as defined in the
- •- Subject has history of certain atypical infections, viral hepatitides, HIV infection, tuberculosis, as defined in the protocol
- •- Subjects receiving any live vaccination within the 8 weeks prior to Baseline
- •- Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB
- •infection or current or history of nontuberculous mycobacteria (NTMB) infection
- •- Subject has immunosuppressive condition or treatment, recent history of malignancy (some exceptions)
- •or demyelinating disease
- •- Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:
- •a. <= 3 excised or ablated basal cell carcinomas of the skin
- •b. One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only
- •(other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more
- •than 2 years prior to Screening
- •c. Actinic keratosis (-es)
- •d. Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior
- •to Screening
- •- Subject has history of psychiatric disorder, including suicidality (as defined in the protocol
- •- Subject has major abnormalities on laboratory testing, as defined in the protocol
- •- Subjects with presence of significant uncontrolled neuropsychiatric disorder, active suicidal ideation, or positive suicide behavior using the Baseline” version of the Columbia-Suicide Severity Rating Scale (C-SSRS) and the Hospital Anxiety and Depression Scale (HADS) with either of the following criteria:
- •a) Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes”) to either question 4 or question 5 of the Screening/Baseline” version of the C-SSRS at screening.
- •b) HADS Depression score =10 or Anxiety score =15.
- •- Subjects with clinically significant EKG-changes
研究者
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